The subject matter described herein relates generally to medical devices and, more particularly, to methods and systems for sealing a puncture of a vessel.
Catheter introducers are known to provide access to an artery for at least some medical procedures including, without limitation, cardiac catheterizations and peripheral endovascular procedures. After conducting such medical procedures, the catheter introducer is removed from the access site, leaving an arterial opening. At least some body fluids including, without limitation, blood are discharged from the arterial opening. Excess blood loss may endanger and/or traumatize the patient. One known method of controlling blood loss is through direct manual pressure over the arterial opening. However, in at least some cases, such as but not limited to medical procedures that require large-bore access through the artery wall, manual pressure alone is not sufficient to achieve hemostasis. For example, at least some such procedures are performed using catheter introducers of 14 Fr to 24 Fr diameter.
Another known method of controlling blood loss at a puncture site is the insertion of an implant, such as an anchor, balloon, disk, or the like, inside the lumen of the artery. The implant is then pulled back within the lumen and against the inner wall of the artery at the puncture site. The implant has a diameter at least slightly greater than the puncture opening, enabling the implant to be positioned to block blood loss through the puncture. However, in at least some cases, such as but not limited to medical procedures that require large-bore access through the artery wall, the required diameter of the implant approaches a diameter of the artery itself, increasing a risk that the implant may encounter an obstacle inside the artery that inhibits proper positioning, such as plaque, a smaller side branch of the artery, or the walls of the artery itself. For example, at least some such procedures result in puncture openings up to 8 millimeters in diameter, and the common femoral artery has an average diameter of 7 to 8 millimeters.
Moreover, in at least some cases, such as but not limited to medical procedures that require large-bore access through the artery wall, the insertion of the catheter introducer creates an inferior flap in the artery wall. A normal, healthy artery is compliant, that is, the inferior flap will recoil and elevate once the large bore procedural sheath is removed. However, at least some patients undergoing large bore cardiovascular procedures have unhealthy arteries. For example, calcium and atherosclerotic plaque are present in the wall of the common femoral artery, causing the artery to lose compliance and the ability to recoil. Thus, in at least some cases, the inferior flap does not elevate back towards the artery wall on its own once the large bore procedural sheath is removed, but rather remains deflected against the posterior wall of the artery. If the inferior flap is not elevated back towards alignment with the puncture opening during the deployment of the implant, there is a risk that the inferior flap will prevent a sufficient seal of the puncture site or obstruct the femoral artery. In at least some cases, the length of the inferior flap created is equal to the diameter of the large bore procedural sheath, for example 5 to 8 millimeters.
Another known method of controlling blood loss at a large bore puncture site is suturing the lumen of the artery. However, suturing the puncture site closed typically requires an incision to expose the artery and/or otherwise is a tedious procedure, and plaque may cause complications in driving the sutures through the vessel wall around the puncture site. Although some known devices have been developed to assist an operator in suturing a vessel puncture site, such known devices do not eliminate the tedious nature of manual suturing and also add a number of non-intuitive steps to the suturing process. Moreover, in at least some cases, the sutures have to be deployed at the beginning of the procedure, prior to the insertion of the large bore procedural sheath and the creation of the inferior flap in the wall of the artery, because after the inferior flap is created, known suturing devices do not successfully capture the inferior flap.